Identity
- Trade Name
- zuvo FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- zuvo 12 speech generating device FDA UDI
- Model / Reference
- 12 FDA UDI
- Description
- zuvo 12 speech generating device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850041729053 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Voice synthesizer/digitizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Voice synthesizer/digitizer
zuvo by Talk To ME Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Voice synthesizer/digitizer.
- Lingraphica — LINGRAPHICARE AMERICA, INC. · Class II
- Chat Fusion — PRENTKE ROMICH COMPANY · Class II
- Nova Chat — PRENTKE ROMICH COMPANY · Class II
- G13 — SMARTBOX ASSISTIVE TECHNOLOGY INC · Class II
- Nova Chat — PRENTKE ROMICH COMPANY · Class II
- Chat Fusion — PRENTKE ROMICH COMPANY · Class II
- PRC Look™ — PRENTKE ROMICH COMPANY · Class II
- Touch Chat — PRENTKE ROMICH COMPANY · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Talk To ME Technologies, LLC
Sources (1)
- FDA UDI 1a46286c-22f2-4361-a867-862330cf12b6 33 fields · synced May 30, 2026